The ethical bureaucracy.

Abstract

Hands up those who think that research ethics committees are doing a good job. Do not expect to see Drs Maskell, Jones and Davies waving. Last month in the QJM, they reported what happened while they were setting up a multicentre study of intrapleural streptokinase.1 They reckoned that the local investigators spent 62 hours photocopying to produce the 25 296 pieces of paper needed to satisfy the 51 local research ethics committees (LRECs) involved. Others have written about similar experiences.2 The present system of research ethics committees in the UK was established in 1997 by the Department of Health. Twelve multicentre research ethics committees (MRECs) were appointed to deal with applications for studies and trials involving patients recruited from within five or more LREC boundaries. The idea was that an MREC would consider the ethical aspects of the study and that, if approval was given, LRECs could only raise objections or insist on modifications to the protocol if there was a particular local issue. This was supposed to save both time for both researchers and LRECs, and by eliminating the large variations in practice among different LRECs, make it easier to carry out multicentre research. Perhaps it was inevitable that there were difficulties at first. Some LRECs saw the new system as a threat to their independence, refused to accept decisions made by MRECs, and continued to demand protocol changes for reasons that were not local.3 Problems at the MREC/LREC interface, however, seem gradually to …